Praxis

Senior Manager, Quality Operations – Commercial, Stability, CMC

Praxis

full-time

Posted on:

Location Type: Remote

Location: Remote • 🇺🇸 United States

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Salary

💰 $120,000 - $132,000 per year

Job Level

Senior

About the role

  • Oversee the 3PL contract service providers (CSPs) for commercial production distribution activities.
  • Review and approve key strategic product/process documents and records.
  • Support commercial stability program management including trending for early Field Alert Reporting notification.
  • Support clinical stability program strategy including product shelf life and execution.
  • Manages mock recall and recall program.
  • Manages the APR/PQR, coordinating cross functionally to ensure regulatory requirements are met.
  • Lead, review and approve change controls, deviations, temperature excursions, investigations, OOX, CAPA, and Product Quality Complaints.
  • Performs risk assessment and implements appropriate quality and process controls to ensure proper oversight of all production activities.
  • Ensure cohesive collaboration across CSPs for timely review of GMP records.
  • Interface with Regulatory Affairs to review, and approve regulatory filings (IND, NDA).
  • Support pre-approval inspection and commercial readiness activities.
  • Support or perform internal and external audits.

Requirements

  • BA or BS degree in Chemistry or related field.
  • 6+ years in a GMP setting working with clinical and commercial products.
  • Experience managing stability programs.
  • Direct experience with recall, APR, FAR management.
  • Firsthand experience with interpreting and implementing regulatory standards (e.g., ISO, FDA, ICH, GMP, EMA).
  • Proven ability to operate independently and influence cross-functionally.
  • Proven track record in supporting regulatory inspections (FDA, EMA).
  • Strong knowledge of quality management systems, QC and development processes, and regulatory strategy for small molecule DS and solid oral drug products.
  • Experience with interfacing with a QP and CSPs.
  • Excellent written, organizational, and oral communication skills.
  • Must thrive working in a fast-paced, innovative environment.
Benefits
  • 99% of the premium paid for medical, dental and vision plans.
  • Company-paid life insurance, AD&D, disability benefits, and voluntary plans.
  • 401(k) contributions matched dollar-for-dollar up to 6%.
  • Long-term stock incentives and ESPP.
  • Discretionary quarterly bonus.
  • Flexible wellness benefit.
  • Generous PTO, paid holidays, and company-wide shutdowns.

Applicant Tracking System Keywords

Tip: use these terms in your resume and cover letter to boost ATS matches.

Hard skills
GMPstability programsrecall managementAPR managementFAR managementregulatory standardsquality management systemsQC processesregulatory strategysmall molecule DS
Soft skills
independent operationcross-functional influenceorganizational skillsoral communicationwritten communication
Certifications
BA degreeBS degree